Job Title: Project Manager/ Business Analyst (Clinical Operations)
Location: Foster City, CA (Hybrid)

Employment Type: Full-Time (FTE)

Job Summary

Seeking a Senior Project Manager / Business Analyst with strong Clinical Operations expertise and hands-on experience in Risk-Based Monitoring (RBM/RBQM). Responsible for requirements gathering, project delivery, stakeholder management, and implementation of clinical systems and monitoring processes.

Key Responsibilities

• Lead requirements gathering for RBM/RBQM, KRIs, QTLs, centralized monitoring, dashboards, and reporting.
• Develop BRDs, FRDs, user stories, workflows, data mappings, acceptance criteria, and traceability matrices.
• Manage project scope, timelines, risks, dependencies, milestones, and stakeholder communications.
• Coordinate with Clinical Operations, Data Management, Quality, Biostatistics, IT, vendors, and QA/UAT teams.
• Support RBQM implementation, testing, validation, change management, and training.
• Ensure compliance with ICH E6(R2/R3), GxP, and 21 CFR Part 11; maintain audit and inspection-ready documentation.

Required Skills

• Experience of Business Analysis and/or Project Management experience in the clinical domain.
• Strong Clinical Operations experience, including RBM/RBQM.
• Strong knowledge of clinical trial lifecycle, monitoring strategies, and inspection readiness.
• Experience with CTMS, RBQM tools, EDC, and eTMF; Veeva Clinical preferred.
• Proficiency in Agile/Scrum, Jira or Azure DevOps, requirements documentation, and UAT.
• Strong communication, analytical, risk management, and stakeholder management skills.
• Ability to work independently in a US-based, onshore-facing role.

Preferred: Veeva Vault Clinical (CTMS, Quality, CDMS), centralized monitoring analytics, Excel reporting, CSV/validation documentation, and vendor management.